CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY

Post-LOE

cetirizine hydrochloride

Signatur Biosciences

ANDAORALSOLUTION

Approved

Apr 2008

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

4/8 — Partial

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY (cetirizine hydrochloride) by Signatur Biosciences is mechanism of actions cetirizine, a human metabolite of hydroxyzine, is an antihistamine; its principal effects are mediated via selective inhibition of peripheral h 1 receptors. Approved for these symptoms due to hay fever, other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose and 1 more indications. First approved in 2008.

Drug data last refreshed 18h ago

Mechanism of Action

Mechanism of Actions Cetirizine, a human metabolite of hydroxyzine, is an antihistamine; its principal effects are mediated via selective inhibition of peripheral H 1 receptors. The antihistaminic activity of cetirizine has been clearly documented in a variety of animal and human models. In vivo…

Indications (4)

these symptoms due to hay fever

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Data Sources

Drug label: DailyMed / FDA
Clinical trials: ClinicalTrials.gov
Patent data: FDA Orange Book
Spending data: CMS Medicare

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.

Clinical Trials (5)

NCT04189588Phase 2Completed

Phase 2 Study IV QUZYTTIR™ (Cetirizine Hydrochloride Injection) vs V Diphenhydramine

Started Mar 2020

34 enrolled

Oncology Patients Receiving Chemotherapy

NCT01064115Phase 1Completed

Cetirizine Hydrochloride Tablets, 10 mg Bioequivalence Study of Dr.Reddy's Under Fed Condition

Started Jan 2006

30 enrolled

Healthy

NCT01064102Phase 1Completed

Cetirizine Hydrochloride Tablets, 10 mg Bioequivalence Study of Dr.Reddy's Under Fasting Condition

Started Jan 2006

30 enrolled

Healthy

NCT00881127Phase 1Completed

To Demonstrate the Relative Bioavailability of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg Extended Release (ER) Tablets Under Fasting Conditions

Started Jul 2005

40 enrolled

Allergies

NCT00881634Phase 1Completed

To Demonstrate the Relative Bioavailability of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg Extended Release (ER) Tablets Under Fed Conditions

Started Jun 2005

40 enrolled

Allergies